NA CU-10520URecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00813250016253), received between May 15, 2020 and Apr 18, 2025 — classified as 2 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (1 report).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryApr 18, 2025Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT FOLLOWING A RADIOFREQUENCY PROCEDURE, THE ATTACHMENT OF THE ELECTRODE TO THE NEEDLE WAS BROKEN OFF AND THE NEEDLE REMAINED IN THE PATIENT WHEN REMOVING THE INJECTION ELECTRODE. THE NEEDLE WAS THEN SURGICALLY REMOVED. IT WAS REPORTED THAT THE PATIENT WAS ADMITTED TO HOSPITAL BEYOND STANDARD OF CARE; HOWEVER, THE PATIENT WAS DISCHARGED THE SAME DAY OF THE PROCEDURE. THE PATIENT IS EXPECTED TO FULLY RECOVER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21868490 ↗
• InjuryMay 15, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING THE RADIOFREQUENCY ABLATION PROCEDURE THE PHYSICIAN REMOVED THE ELECTRODE FROM THE PATIENT AND SAW A PIECE OF METAL WIRE REMAINED IN THE PATIENTS BODY. AN X-RAY WAS PERFORMED AND FOUND THAT THE WHOLE CU CANNULA WAS STILL SITTING IN THE LOCATION WHERE THE PROCEDURE WAS PERFORMED. A NEUROSURGEON WAS CALLED IN TO PERFORM A SURGICAL PROCEDURE IN WHICH THE CANNULA WIRE WAS REMOVED. THE PATIENT HAS RECOVERED AND IS DOING WELL POST-OPERATIVELY.

  Patient problems: No Code Available

  MAUDE report 10062475 ↗